- J&J Family of Companies (Titusville, NJ)
- …direct supervision to the CTA team responsible for the delivery of compliant regulatory submissions required to support the development and registration of ... + Lead and oversee a CTA team in planning, preparing, and maintaining regulatory submissions and filings, ensuring accuracy and compliance throughout the… more
- Sumitomo Pharma (Trenton, NJ)
- …agencies. + Understands evolving Health Authority (HA) standards and procedures for regulatory submissions . Guides and trains project teams on new requirements, ... of external publishing staff contracted to publish and dispatch health authority submissions . + Represents Regulatory Operations on project teams for matters… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …advanced degree prefferred. + Demonstrated success in the preparation and completion of regulatory submissions (Qsub, PMA, 510(k), IDE) to FDA and other global ... Specialist is responsible for preparation of US and CE marking submissions /registration activities, completing comprehensive regulatory assessments for product… more
- System One (Florham Park, NJ)
- … information management tasks including file transfer, storing, tracking, and archiving of regulatory submissions . + Maintain knowledge of local regulatory ... DMF). + Ensure consistency across regulatory submission documents following the regulatory style guide (ie formatting, reviewing, and submissions ). + Provide… more
- Stryker (Mahwah, NJ)
- … regulatory skills. You will participate in cross-functional teams, develop global regulatory strategies, author regulatory submissions , interact with ... support the proposed product claims + Prepare and submits electronic and paper regulatory submissions according to applicable regulatory requirements and… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA). - RAC ... planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …compliance. They participate on cross-functional teams, lead the development of global regulatory strategies, author regulatory submissions , interact with ... labeling in consideration of US, EU, and other global regulatory requirements. + Authors FDA submissions , EU technical files, and other regulatory documents… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …the Global Regulatory Lead for early-stage or other programs. You will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent ... regulatory authorities. You will oversee preparation and maintenance of regulatory submissions , regulatory labeling and packaging for assigned products or… more
- Grifols Shared Services North America, Inc (New Brunswick, NJ)
- …the scope of experimentation and the selection of data needed to support regulatory submissions . + Interacts with regulatory authorities regarding programs ... and development of contingency plans. + Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements… more
- Stryker (Mahwah, NJ)
- …authority interactions with internal teams + Ensure quality and compliance of regulatory submissions , labeling, and marketing materials + Communicate and ... + Understanding of global medical device regulations including direct experience with regulatory submissions associated with US and EU Class II/III medical… more
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